Anavex Life Sciences Corp (AVXL)

[TempePhil]

This FDA link describes all 4 designations.

FDAs four designations- link

As I see it, for Alz, Blarc easily qualifies for Priority Review and Fast Track designations.
Blarc may not qualify for Breakthrough Therapy and Accelerated approval, as they are generally linked to accepted “surrogate endpoints”. As you point out, Anavex does not seem to have any designated surrogates in any trial. (FYI it was the Accelerated Approval pathway that Biogen was able to use based on “reduction in brain amyloid as measured by PET”. Where amyloid was an accepted surrogate.

On the other hand, Blarc may quailfy for Breakthrough Therapy, meeting the requirement of “A significantly improved safety profile compared to available therapy, with evidence of similar efficacy.”